LAMOTRIGINE Drug Patent Profile
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Which patents cover Lamotrigine, and what generic alternatives are available?
Lamotrigine is a drug marketed by Actavis Elizabeth, Amneal Pharms, Anchen Pharms, Dr Reddys Labs Ltd, Par Pharm, Rubicon, Torrent, Wockhardt Bio Ag, Yiling, Zydus Pharms, Alembic, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Mylan, Sandoz, Taro, Teva, Watson Labs, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Amring Pharms, Impax Labs Inc, Sciegen Pharms Inc, Actavis Totowa, Alembic Pharms Ltd, Alkem Labs Ltd, Chartwell Molecular, Glenmark Generics, Granules, Hikma Pharms, Jubilant Cadista, Lupin Ltd, Mylan Labs Ltd, Rising, Roxane, Taro Pharm Inds, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa. and is included in forty-nine NDAs.
The generic ingredient in LAMOTRIGINE is lamotrigine. There are thirty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lamotrigine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lamotrigine
A generic version of LAMOTRIGINE was approved as lamotrigine by DR REDDYS LABS LTD on January 22nd, 2009.
Summary for LAMOTRIGINE
US Patents: | 0 |
Applicants: | 41 |
NDAs: | 49 |
Finished Product Suppliers / Packagers: | 50 |
Raw Ingredient (Bulk) Api Vendors: | 150 |
Clinical Trials: | 209 |
Patent Applications: | 4,366 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LAMOTRIGINE |
Drug Sales Revenues: | Drug sales revenues for LAMOTRIGINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LAMOTRIGINE |
What excipients (inactive ingredients) are in LAMOTRIGINE? | LAMOTRIGINE excipients list |
DailyMed Link: | LAMOTRIGINE at DailyMed |
Recent Clinical Trials for LAMOTRIGINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Inge Winter | Phase 4 |
Westfälische Wilhelms-Universität Münster | Phase 4 |
Dr Cipto Mangunkusumo General Hospital | Phase 4 |
Pharmacology for LAMOTRIGINE
Drug Class | Anti-epileptic Agent Mood Stabilizer |
Mechanism of Action | Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LAMOTRIGINE
Paragraph IV (Patent) Challenges for LAMOTRIGINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LAMICTAL XR | Extended-release Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg | 022115 | 1 | 2014-02-12 |
LAMICTAL ODT | Orally Disintegrating Tablets | lamotrigine | 25 mg, 50 mg, 100 mg, and 200 mg | 022251 | 1 | 2009-12-21 |
US Patents and Regulatory Information for LAMOTRIGINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva | LAMOTRIGINE | lamotrigine | TABLET, FOR SUSPENSION;ORAL | 076420-001 | Jun 21, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actavis Totowa | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078669-003 | Apr 8, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Wockhardt Bio Ag | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202498-003 | Jan 4, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rubicon | LAMOTRIGINE | lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 202887-002 | Jun 17, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Taro Pharm Inds | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078525-002 | Jan 27, 2009 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Roxane | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 077392-004 | Jan 27, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amring Pharms | LAMOTRIGINE | lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 214124-004 | Feb 3, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |